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Recall Observatory FDA recall evidence

Device product

DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

Z-2073-2026

March 25, 2026

Class II

Product summary

Firm
Katalyst Surgical, LLC
Event
Event 98660
Status
Ongoing
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-2073-2026

Official wording

Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Code information: Lot Code: Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250807(17)280807(10)M49267 Lot Number: M49267 Expiration Date: 08/07/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251017(17)281017(10)M50930 Lot Number: M50930 Expiration Date: 10/17/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251113(17)281113(10)M51230 Lot Number: M51230 Expiration Date: 11/13/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251212(17)281212(10)M51587 Lot Number: M51587 Expiration Date: 12/12/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)260115(17)290115(10)M51696 Lot Number: M51696 Expiration Date: 01/15/2029 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250904(17)280904(10)M49921 Lot Number: M49921 Expiration Date: 09/04/2028 Model No; DVF4019-23 UDI-DI: (01)10817489022136(11)251107(17)281107(10)M51128 Lot Number: M51128 Expiration Date: 11/07/2028

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Field Safety Corrective Action for IFU in DEX Forceps and Scissors.